出口防疫器械有质量问题的，企业立即停产，问责！

admin · 发表于 2020-10-14 12:35:59

                  <section data-role="paragraph" data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.png" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><p><br  /></p><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><p><span>近期，国外防疫物资需求激增，我国企业在大量出口的同时也出现了许多问题，像前一段时间荷兰召回60万支不符合标准的中国口罩，美国也因部分国产口罩标准低于FDA要求而拒绝进口。为此，药监局出台了严格的监管政策：</span></p></section></section></section></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section><br  /></section></section></section><section><section powered-by="gulangu"><p><span><strong><span>严查出口防疫器械</span></strong></span></p><p><br  /></p></section></section></section><section powered-by="gulangu"><p><span>4月3日，国家药监局召开全面加强疫情防控医疗器械出口质量监管工作专题电视电话会议，国家药监局副局长徐景和出席并讲话。</span></p><p><br  /></p><span>当前，国际疫情呈现蔓延之势，我国在满足自身需求的同时，也向海外市场供给了大批防疫医疗器械。保障防疫医疗器械质量，关乎国家形象和声誉，国家局将严查出口防疫用户，发现质量不合格的产品将做停产处理。</span><p><br  /></p><p><p><img src="image/20201014/d77c8fe1f1f50b4f4c2a2c6f299964c8_2.jpg" /></p></p><p><br  /></p><p><strong><span>会议明确要求：</span></strong></p><p><br  /></p><p><span>1）要迅速摸清企业情况，确保监管突出重点。各省级药品监管部门要建立出口医疗器械企业清单，实行动态调整，对医疗器械生产企业和经营企业出口医疗器械产品，做到心中有数；监督指导出口企业完善出口产品档案，切实保证产品出口过程的可追溯；及时将出口企业清单通报企业所在地政府。</span></p><p><br  /></p><p><span>2）确定专人负责上报，确保信息公开质量。国家局已将药品监管部门批准注册的5类产品（新冠病毒检测试剂、医用防护服、医用口罩、呼吸机、红外体温计）在国家药监局网站持续集中公开；各省级药品监管部门要指定专人负责信息上报。</span></p><p><br  /></p><p><span>3）准确把握法律定位，规范出口销售证明。对未在我国取得医疗器械注册证书及生产许可证书、或者未办理医疗器械产品备案及生产备案的企业，一律不得出具出口销售证明。</span></p><p><br  /></p><p><span>4）组织系统精干力量，加大监督检查力度。各省级药品监管部门要迅速调集全省资源，建立医疗器械生产经营企业清单制和监管人员责任制，针对重点对象，围绕关键环节，聚焦突出问题，强化控制措施，<strong>凡是有证据表明出口产品质量存在问题的，要立即停产、整顿，并查清问题。问题未查实，责任未分清的，不得恢复生产、经营</strong>。</span></p><p><br  /></p><p><span>5）突出出口产品监管，强化监督抽检力度。各省级药品监管部门要根据疫情防控需要和保障出口产品质量的需要，适当调整抽检项目。抽检要涵盖本省企业生产的各类产品，尤其是疫情防控期间新批准企业生产的产品。<br  /></span><br  /></p><p><span>针对监管中发现的违法违规行为，会议强调，要贯彻“四个最严”要求，严格落实企业主体责任和属地管理责任，对违法违规案件，发现一起查处一起，依法严惩绝不姑息。<strong>强化重大案件挂牌督办，强化案件行刑衔接，突出违法行为处罚到人，形成高压态势和震慑威力</strong>。<br  /></span><br  /></p><p><span>据悉，<strong>国家药监局将与市场监管总局相关司局，组成联合督导组，赴部分疫情防控医疗器械出口量较大的地区进行专项督导，并将各地疫情防控医疗器械出口产品质量监管纳入年度考核评价</strong>。</span><br  /><br  /></p></section><section powered-by="gulangu"><section><section powered-by="gulangu"><p><span><strong><span>欧盟、美国对口罩等防疫用品的准入要求</span></strong></span></p><p><br  /></p></section></section></section><section powered-by="gulangu"><p><strong><span>欧盟对口罩等防疫用品准入要求</span></strong></p><p><strong><span><br  /></span></strong></p><p><span><strong>（一）口罩</strong></span></p><p><span><strong><br  /></strong></span></p><p><span>欧盟根据用途将口罩分为两类：医用口罩和个人防护口罩。</span></p><p><br  /></p><p><span>1、医用口罩</span></p><p><br  /></p><p><span>医用口罩需按照欧盟医疗器械指令93/42/EEC（MDD）或欧盟医疗器械条例EU2017/745（MDR）加贴CE标志，对应的标准是EN14683。根据口罩产品无菌或非无菌状态，采取的合格评定模式也不同。</span></p><p><br  /></p><p><span>（1）无菌医用口罩：必须由授权公告机构进行CE认证。</span></p><p><span>（2）非无菌医用口罩：企业只需进行CE自我符合性声明，不需要通过公告机构认证。在准备好相应文件及测试报告等资料后，即可自行完成符合性声明。</span></p><p><br  /></p><p><span>2、个人防护口罩</span></p><p><span>个人防护口罩不属于医疗器械，但需符合欧盟个人防护设备条例EU2016/425（PPE）要求，由授权公告机构进行CE认证并颁发证书，对应的标准是EN149。</span></p><p><br  /></p><p><p><img src="image/20201014/8a01c01082e2c1b306db0a3e9c03810b_3.jpg" /></p></p><p><br  /></p><p><strong><span>（二）防护服</span></strong></p><p><span>防护服也分为医用防护服和个人防护服，管理要求与口罩基本类似。医用防护服按照医疗器械管理，其中无菌医用防护服需按照欧盟医疗器械指令93/42/EEC（MDD）或欧盟医疗器械条例EU2017/745（MDR）获得CE认证，非无菌医用防护服只需进行CE自我声明。个人防护服需按照欧盟个人防护设备条例EU2016/425（PPE）获得CE认证。</span></p><p><span><br  /></span></p><p><strong><span>（三）欧盟公告机构查询地址</span></strong></p><p><span>1、欧盟医疗器械指令93/42/EEC（MDD）授权的公告机构查询地址：</span></p><p><span>https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13</span></p><p><span>2、欧盟医疗器械条例EU 2017/745（MDR）授权的公告机构查询地址：</span></p><p><span>https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34</span></p><p><span>3、欧盟个人防护装备条例EU2016/425（PPE)授权的公告机构查询地址：</span></p><p><span>https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=155501</span></p><p><br  /></p><p><span><strong>美国对口罩等防疫用品准入要求</strong></span></p><p><span><strong><br  /></strong></span></p><p><strong><span>（一）口罩</span></strong></p><p><strong><span><br  /></span></strong></p><p><span>美国对医用口罩和防护口罩同样区分管理，其中医用口罩由美国食品药品监督管理局（FDA）管理，而个人防护口罩则由美国国家职业安全卫生研究所（NIOSH）管理。</span></p><p><span><br  /></span></p><p><span>1、医用口罩</span></p><p><span>医用口罩需通过FDA注册，企业直接向FDA官网申请并提交相关材料。此外还有两种可选途径：</span></p><p><span><br  /></span></p><p><span>（1）已经获得NIOSH注册的N95口罩，在产品生物学测试、阻燃测试和血液穿透测试通过的情况下，可以豁免产品上市登记（510K），直接进行FDA工厂注册和医疗器械列名。<br  /></span></p><p><span>（2）如果获得持有510K的制造商的授权，可以作为其代工厂使用其510K批准号进行企业注册和器械列名。</span></p><p><span><br  /></span></p><p><span>2、个人防护口罩</span></p><p><span>防护口罩需通过NIOSH注册，企业直接在NIOSH官网申请。</span></p><p><br  /></p><p><strong><span>（二）防护服</span></strong></p><p><span><br  /></span></p><p><span>对医用防护服和个人防护服的管理也类似于口罩的管理方式，其中医用防护服由美国食品药品监督管理局（FDA）管理，而个人防护服由美国国家职业安全卫生研究所（NIOSH）管理。企业直接在FDA或NIOSH进行注册申请。</span></p><p><br  /></p></section><section powered-by="gulangu"><section><section powered-by="gulangu"><p><strong><span>中国境内具有口罩等防疫用品CE认证能力的认证机构名录</span></strong></p></section></section></section><section powered-by="gulangu"><p><p><img src="image/20201014/0091877ce91ff44a340669b09f39213a_4.jpg" /></p></p><p><br  /></p></section><section powered-by="gulangu"><section><section powered-by="gulangu"><p><strong><span>中国境内可以开展医疗器械管理体系（ISO13485）认证的机构名录</span></strong></p></section></section></section><section powered-by="gulangu"><p><strong><p><img src="image/20201014/97848a0278821b99e0c401570be75120_5.jpg" /></p></strong></p></section><p><br  /></p><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="paragraph"><section><section><section data-brushtype="text"><strong>相关阅读</strong></section></section></section><section><section><br  /></section></section><section data-width="100%"><section><section><section><section data-width="100%"><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><section><p><img src="image/20201014/2aac877ff9233ba5a66e7a5ff3a4febf_6.gif" /></p></section><section data-brushtype="text">戳一下，更有料！</section></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973277&idx=1&sn=071f8522d99a3d4f98c232bc66231b10&chksm=843f4a4ab348c35c64a4807b21dbbdb58c5e21baf975e80cd5a02e657098a7cee39bcdd1085b&scene=21#wechat_redirect" data-itemshowtype="11" tab="innerlink" data-linktype="2"><span>ECMO三巨头：迈柯唯、美敦力和索林大比拼！</span></a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973277&idx=2&sn=a4f5a277a27841e7015715991eed07a2&chksm=843f4a4ab348c35c8358de6fd89218653abca54cbd316efdddf4c8d0721aa0f1e87c112c242f&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2"><span>全球抗疫新动态，微软研发疫苗，苹果日产百万防护面罩！</span></a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973277&idx=3&sn=5a5373133dd9c9bc3924a0bf8dbf5e66&chksm=843f4a4ab348c35c304b5e4e3b69e67db75bdaffb54fef84c72e42ffed1edf58e2c980e6d6d7&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2"><span>一图读懂 CT 机</span></a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973257&idx=2&sn=955c5ccf9d64c531b277c498b4205094&chksm=843f4a5eb348c348ce4939130ce5bd7e546479c09b93de7b1c593e62ea8e2d8f7693541f0c36&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2"><span>华为又建医疗公司！5G、可穿戴设备、数字医疗！不断扩大的医疗版图！</span></a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973239&idx=2&sn=8b6552f2ff1b05005ffd7fbabf193744&chksm=843f4a20b348c336deff78ad48d1ec0465c2115485f13ade9019b7fde4dd0a51cbb6fcd9f41a&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2"><span>马斯克宣布：免费向全世界医院提供呼吸机</span></a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973187&idx=1&sn=21a67976fbdcdd61e068fad865dc4507&chksm=843f4a14b348c302cba4efcba6ea8fe243120afb313a468ff5add9186634ff5335de28c6e89d&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2">先睹为快！世界首台“自屏蔽”立体定向放射外科设备Zap-X！</a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973187&idx=2&sn=92f1b65e36efdc763809cb396727c2df&chksm=843f4a14b348c3023fe3930525090a6d656379d9fd394f27523108763a3e32e97b37feaffd4f&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2">呼吸机告急，国内外多家供应商紧急增产</a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973187&idx=3&sn=f7452f132b2c4461461945b1cc694d57&chksm=843f4a14b348c3024984c8d8adad0067d208a482c711c4cbdd632719484bb173bcd27c8cdaa1&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2">中国抗疫花了多少钱？</a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973181&idx=1&sn=80f36008aab8055449bba0e3a75f223e&chksm=843f4aeab348c3fcac9716554ac83b51c5916051af420bdd5ff2f2df3cff787ccff5f74f2a86&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2">5分钟出结果！雅培推出ID NOW COVID-19检测试剂盒！</a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973171&idx=1&sn=4fc7d0c13dc468edd6669da4b68cf32e&chksm=843f4ae4b348c3f2fb3f4e9ab5c0ccc9657e4cc2959c227ac792925afd5f0e1233c122004165&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2">GE医疗首推全流程AI磁共振技术平台“智简AI” ，开启MR+AI 3.0时代</a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973134&idx=1&sn=032dfeeeba88b7043c04452dbbac381d&chksm=843f4ad9b348c3cf612f90fce313bf5ead288eeee0ce1dcf5a882310a7041f697c32a9ee4b82&scene=21#wechat_redirect" data-itemshowtype="11" tab="innerlink" data-linktype="2">关于方舱CT的一切！</a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973131&idx=1&sn=e16b95b4d0fbccf63c90469e1938b2ea&chksm=843f4adcb348c3cabb7d77fe8d4f499e684c982759ce9878be8c2b6922fd69e492aae78f7774&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2">我国首台自主知识产权重离子治疗系统完成首例患者治疗！</a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973131&idx=2&sn=c5bf2c0809bf3bc8a941b8a42e0b6deb&chksm=843f4adcb348c3ca4b4a353053b93f539e690be5584195cd73e170951bf6f894b5e31881e4ce&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2">正式登陆中国，顶级手术机器人ROSA One通过NMPA审核</a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973084&idx=1&sn=8c4b2d7ef78dc7b413dbfd6dab1fef2b&chksm=843f4a8bb348c39df49c68c11e6f98a6e2d59bdd04867e1d48915bdee2e229c062390596d584&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2">Radixact+RefleXion X1两款放疗设备全新上线！</a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973105&idx=2&sn=54e81c7be78328ae9a4fab49f1a1a400&chksm=843f4aa6b348c3b03551920861135948282d3371c7558d1649830c01219a14409aaf6c052ccf&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2">各国方舱医院都长啥样？</a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><p><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973070&idx=1&sn=57734440324824393ca57f9929bd1486&chksm=843f4a99b348c38f3b37d075aa6132ada223a391106d36197b38ce5574b2ec047fa872632e1c&scene=21#wechat_redirect" textvalue="全球紧缺的ICU究竟需要哪些设备？" data-itemshowtype="0" tab="innerlink" data-linktype="2"><span>全球紧缺的ICU究竟需要哪些设备？</span></a></p><p><br  /></p><p><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652973064&idx=1&sn=0bedc48c46e2a273939dd44d31f36d27&chksm=843f4a9fb348c389d709a3498969fb1d843f0c9a5a3ea5a61a130fb22e2031877838be665be3&scene=21#wechat_redirect" textvalue="江湖救急！各国都缺的呼吸机，这些厂家生产！" data-itemshowtype="0" tab="innerlink" data-linktype="2"><span>江湖救急！各国都缺的呼吸机，这些厂家生产！</span></a></p><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652972972&idx=3&sn=4c5810961c7d9b1726e6653320d2e37f&chksm=843f453bb348cc2d28e717fc16629f2c615b62b74ac95488eba82d781f8ead319d61835f1e13&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1">新冠病毒检测试剂盒研发技术不断突破，检测时间最快2分钟</a><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MzA4NDIwMzUxMg==&mid=2652972959&idx=1&sn=23767c0caba81e82cb4d0b3c226b2aed&chksm=843f4508b348cc1e9fa631afb2b7ca4772f8a61c16818a927be204e33c6ea4780e1f1cd04edc&scene=21#wechat_redirect" data-itemshowtype="0" tab="innerlink" data-linktype="2" hasload="1">中国医疗器械正在拯救世界</a></section></section></section></section></section></section></section></section></section><p><br  /></p><p><p><img src="image/20201014/aad9f56b0707b5374bbac6273a663447_7.jpg" /></p></p>

		自动登录	找回密码
密码			立即注册